(29 days)
Not Found
No
The 510(k) summary describes a mechanical prosthetic device and its modifications, with no mention of AI or ML technology in its design, function, or intended use.
Yes
The device is described as a prosthetic replacement intended to relieve pain, disability, and correct functional deformities, which are therapeutic actions.
No
The device is a prosthesis intended for total elbow arthroplasty, which is a treatment, not a diagnostic procedure.
No
The device description explicitly states it is a "Total Elbow Prosthesis" and describes physical components like stems, alloys, and a locking mechanism, indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a prosthesis for total elbow arthroplasty, used to replace the elbow joint. This is a surgical procedure performed in vivo (within the body).
- Device Description: The description reinforces that it's a physical implant used to treat conditions of the elbow joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases: to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformities; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Total Elbow Prosthesis is intended for cemented use only.
Product codes
JDB, JDC
Device Description
Total Elbow replacement are used to treat a number of clinical conditions such are severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. It is also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of such surgery is to restore the elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Total Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.
The present Device Modification submission corresponds to :
- the addition of one ulnar longer stem with the same diameter to the previous range with the same indications for use already covered by the previous 510(k) clearance,
- the addition of the possibility to manufacture some components in an other grade of CoCr alloy, the manufacturing method is unchanged compared to the previous 510(k) clearance,
- the modification of the locking mechanism of the ulnar cap. -
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973357, K955099, K000003, K011567
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
031218
Implants Chirurgicaux
MAY 1 6 2003
Summary of Safety and Effectiveness information Special 510(k) - Tornier Total Elbow Prosthesis
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
| 1) Device name | |
|---|---|
| Trade name: | Tornier Total Elbow Prosthesis |
| Common name: | Total Elbow Prosthesis |
| Classification name: | Elbow joint metal/polymer semi-constrained cemented prosthesis |
| Elbow joint metal/metal or metal/polymer constrained cemented prosthesis |
-
Submitter Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France
-
Company contact Tornier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mireille.lemery@tornier.fr
-
Classification Device class: Class II Classification panel: Orthopedic Product code: JDB and JDC § 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis & 888.3150 Elbow joint metal/metal or metal/polymer constrained cemented prosthesis
5) Equivalent / Predicate device
Coonrad / Morrey Total Elbow, Zimmer (K973357) Sorbie - Questor Elbow System, Wright (K955099) Tornier Total Elbow Prosthesis, Tornier (K000003 and K011567)
Image /page/0/Picture/11 description: The image shows a logo with two letters, "T" and "P", intertwined within a hexagon. The letter "T" is at the top, partially overlapping the letter "P" below it. The logo is black and white, with the letters and the outline of the hexagon in black against a white background.
TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B
Page 1/ page 2
SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
1
Implants Chirurgicar
6) Device description
Total Elbow replacement are used to treat a number of clinical conditions such are severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. It is also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of such surgery is to restore the elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Total Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.
The present Device Modification submission corresponds to :
- the addition of one ulnar longer stem with the same diameter to the previous range with the same indications for use already covered by the previous 510(k) clearance,
- the addition of the possibility to manufacture some components in an other grade of CoCr alloy, the manufacturing method is unchanged compared to the previous 510(k) clearance,
- the modification of the locking mechanism of the ulnar cap. -
7) Materials
Humeral implant components are available in CoCr alloy according to standard ISO 5832-12 or ISO 5832-4. The ulnar and radial components are made of CoCr alloy according to standard ISO 5832-7 or ISO 5832-12 or ISO 5832-4, and UHMWPE according to standard ISO 5834-2.
8) Indications
The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases: to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformities; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Total Elbow Prosthesis is intended for cemented use only.
KO 3/2/18
Page 2/ page 2
Image /page/1/Picture/14 description: The image is a black and white logo. The logo consists of a hexagon shape with a stylized letter "T" inside. The letter "T" is bold and has a unique design, with the top part of the "T" extending beyond the hexagon's top edge.
TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE
Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33
S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B
SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mireille Lémery Regulatory Affairs & Quality Engineer Tornier S.A. ZIRST – 161, rue Lavoisier 38330 Montbonnot - France
MAY 1 6 2003
Re: K031218
Trade/Device Name: Tornier Total Elbow Prosthesis Regulation Numbers: 21 CFR 888.3150; 21 CFR 888.3160 Regulation Names: Elbow joint metal/polymer constrained cemented prosthesis. Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: JDC, JDB Dated: April 2, 2003 Received: April 17, 2003
Dear Ms. Lémery:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Mireille Lémery
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
sincerely yours,
Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 00
| S | C | |
|---|---|---|
| ALL CHRIS COLLEGIA |
510(k) Number (if known): K031218
Tornier Total Elbow Prosthesis Device name:
Indication for use:
The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases: to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformities; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Total Elbow Prosthesis is intended for cemented use only.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices | |
| 510(k) Number | K031218 |
| Prescription use | OR Over-The-Counter Use |
(Per 21 CFR 801.109)
(Optional format 1-2-96)